Budget 2027: what it means for medical device companies.
The budget does not touch MDA’s rules or fees. It does put more than RM770 million into public hospital equipment, change sales tax for supplies to manufacturers, fund mid-tier device companies and reshape how private hospitals bill. Here is each measure that matters to a device business, read from the Ministry of Finance’s own documents.
More public equipment spending, no MDA changes.
Prime Minister and Finance Minister Anwar Ibrahim tabled Budget 2027, the Supply Bill (2027), in the Dewan Rakyat on 9 October 2026. The Ministry of Health’s allocation rises to RM47.7 billion from RM46.5 billion, with more than RM770 million for advanced and modern equipment and RM1.2 billion for maintaining and repairing public hospitals and clinics. The speech names medical devices once, in a RM2.1 billion funding line for mid-tier companies. Neither the speech nor its 36 tax-measure appendices mention the Medical Device Authority, Act 737 or MDA fees, so registration, licensing and conformity assessment are unchanged.
For a device company, the practical effect is this: if you want a share of 2027’s public equipment spending, your establishment licence, GDPMD certification and device registrations need to be in place before the tenders open.
Budget 2027 measures that affect device companies
| Measure | What the budget says | Who it matters to |
|---|---|---|
| MOH equipment | More than RM770 million: haemodialysis upgrades at public hospitals nationwide, 400 new ambulances for MOH hospitals, robotic surgery at Hospital Pakar USM, simulation equipment and basic science labs for 18 MOH training institutes | Importers, distributors and authorised representatives that bid for public tenders |
| Hospital and clinic maintenance | RM1.2 billion to maintain and repair all public hospital and clinic infrastructure, including dilapidated clinics | Service and maintenance providers |
| New facilities | Nine, including a specialist clinic and day care complex at Hospital Sultanah Aminah (Johor), a dental specialist centre in Kuching and integrated health complexes in Gerik and Rembau | Suppliers of fit-out equipment |
| Screening and outsourcing | RM200 million to outsource patients, expanded to newborn screening, prenatal genetic testing and rehabilitation; free thalassaemia screening extended to husbands and children of carriers; RM80 million for PeKa B40 screening, medical equipment assistance and cancer treatment incentives | IVD suppliers, rehabilitation equipment suppliers |
| Sales tax refund | From 1 January 2027, local traders and distributors can reclaim sales tax paid on machinery, spare parts and equipment supplied to manufacturers | Device manufacturers and their machinery suppliers |
| Accelerated capital allowance | Locally manufactured plant and machinery, ICT equipment and software: 20% initial and 40% annual allowance, extended for spending from 1 January 2027 to 31 December 2030 | Manufacturers investing in production lines |
| Mid-tier funding | RM2.1 billion from the NIMP fund, KWAP’s Dana Pemacu and Khazanah’s MTC Fund for mid-tier companies in E&E, digital, aerospace and medical devices | Growing Malaysian device manufacturers |
| MSME tax rates | 14% on the first RM150,000 of chargeable income (from 15%) and 16% on RM150,001 to RM600,000 (from 17%), from year of assessment 2027 | Small distributors, importers and manufacturers |
| Private healthcare | MediAsas plan from January 2027 with charges by diagnosis and treatment category; standardised private hospital billing from 2027; e-CKAPS online licensing for private healthcare facilities from 2027 | Suppliers to private hospitals and new clinics |
| Electronic medical records | MCMC investment of RM1 billion to continue the EMR rollout across healthcare facilities | Health software developers |
| Elderly care and disability | Service tax on elderly care cut from 8% to 6% from 1 January 2027, with care fees up to RM96,000 a year exempt; monthly aid for bedridden persons with disabilities and chronically ill patients raised from RM500 to RM600; 15 community rehabilitation premises upgraded into therapy centres | Home-care, rehabilitation and assistive device suppliers |
Selling into the RM770 million equipment spend
Public hospital equipment is bought by tender, and the rules for who may bid changed this year. Under MDA Circular Letter No. 1/2026, in force since 28 January 2026, every tenderer must hold a valid MDA establishment licence before taking part in any new medical device tender. Before a 2027 tender is advertised, you need:
- An establishment licence for each role you play (importer, distributor or authorised representative), under section 15 of Act 737. See our establishment licence page.
- GDPMD certification, which is a condition of that licence for importers, distributors and authorised representatives. See GDPMD.
- A registration for every device you supply, unless an exemption applies. Dialysis machines, dialysers, bloodlines and surgical robots are all medical devices. Start with classification; devices already approved by a recognised regulator can use the verification route.
- Installation, testing and commissioning procedures for active devices. Haemodialysis machines and robotic surgery systems are active devices, so the supplier needs documented procedures under GDPMD paragraph 28 and MS 2058, and the hospital must ensure they are properly installed, tested, commissioned and maintained under section 43 of Act 737. See testing and commissioning.
Notes on the four named items:
- Ambulances. The vehicles are not medical devices. The equipment fitted in them, such as defibrillators, patient monitors, ventilators and suction units, is, and must be registered.
- Hospital Pakar USM is Universiti Sains Malaysia’s hospital, not an MOH hospital. The speech says the robotic surgery system will widen treatment options for patients in the East Coast and northern Peninsular Malaysia. MDA’s registration and licensing rules apply to it in the same way.
- Training equipment. Simulators and laboratory equipment used only for training are not used on patients. Whether a given product is a medical device depends on its intended purpose; an MDA product classification letter settles borderline cases.
- Imports from mid-2027. MDA has postponed enforcement of the medical device import permit to 1 July 2027. Equipment imported for 2027 contracts after that date needs an import permit for each shipment, so build it into delivery schedules.
The speech also says that once the Government Procurement Act comes into force in 2027, the Government will publish project information, including the contractors involved and contract values.
Manufacturers: sales tax, capital allowances and funding
Sales tax refund facility
Manufacturers are already exempt from sales tax on machinery, spare parts and equipment under Item 55, Schedule A, Sales Tax (Persons Exempted from Payment of Tax) Order 2018, but only when they import directly or buy from a local registered manufacturer. Buying the same machine from a local trader or distributor carries sales tax with no exemption. From 1 January 2027, the trader or distributor can reclaim the sales tax it paid on goods supplied to manufacturers (Appendix 33 of the tax measures).
The refund also extends to inputs, but only to inputs for pharmaceutical products, animal feed, fertilisers and pesticides listed in Schedule B. Raw materials and components for making medical devices are not on that list. A combination product regulated as a pharmaceutical by NPRA is a different case; see our combination products page for which agency regulates what.
Accelerated capital allowance
The accelerated capital allowance for heavy machinery and for plant and general machinery bought from local manufacturers, ICT equipment and software, and customised software development fees (20% initial allowance, 40% annual allowance, fully claimed within two years) was due to end on 31 December 2026. Budget 2027 extends it to spending from 1 January 2027 to 31 December 2030 (Appendix 28).
RM2.1 billion for mid-tier companies
RM2.1 billion from the NIMP fund, KWAP’s Dana Pemacu and Khazanah’s MTC Fund will be used to strengthen mid-tier companies in E&E, digital technology, aerospace and medical devices. The speech gives no eligibility rules or application process; those will come from the fund managers. For manufacturers planning to export, ISO 13485 and the target market’s approval, such as CE marking, FDA 510(k) or an MDSAP audit, are usually the long-lead items.
Private hospitals, clinics and health software
- MediAsas launches in January 2027. Hospital charges under the plan are based on diagnosis and treatment categories, so costs are controlled and predictable. EPF members under 55 can pay premiums from their Sejahtera Account, and SMEs with fewer than 75 employees get a RM200 per employee subsidy on the first-year premium, capped at 50 employees. Our view: when a hospital is paid a set amount per case, the cost of the devices used in that case gets more scrutiny.
- Private hospital billing will use standardised, transparent fee categories from 2027.
- e-CKAPS, a portal for fully online licensing of private healthcare facilities, is due from 2027 and targets processing times up to 65% shorter. Faster licensing means new clinics equip sooner. Every clinic using devices on patients is bound by section 43 of Act 737.
- Electronic medical records. MCMC will invest RM1 billion to continue the EMR rollout across healthcare facilities, and records will be expanded on a “one individual, one record” principle. A system that only stores and displays records is not a medical device under MDA/GD/0063. A module that analyses patient data for diagnosis or monitoring can be. See software as a medical device.
Home care, elderly care and disability
- Elderly care service tax. From 1 January 2027, elderly care moves to a new item in Group I of the Service Tax Regulations 2018, at 6% instead of 8%. Care centres registered under the Care Centres Act 1993 or the Private Aged Healthcare Facilities and Services Act 2018 are exempt on fees up to RM96,000 a year per person (Appendix 34). A Senior Citizens Bill will be drafted, and two integrated care centres (NICE) will be built in Pulau Pinang and Sarawak.
- Disability. Total assistance for persons with disabilities rises to RM1.5 billion, monthly aid for bedridden persons with disabilities and chronically ill patients goes from RM500 to RM600, and 15 community rehabilitation (PDK) premises become specialised therapy centres for people with Down syndrome.
- Individual tax relief. From year of assessment 2027, the RM10,000 medical treatment relief becomes Health and Well-being relief. It adds postnatal care (up to RM3,000) and absorbs the breastfeeding equipment relief (up to RM1,000, for children aged 2 and below). Self-health monitoring equipment stays in the RM1,000 sub-limit with medical examinations and diagnostic tests. Relief for parents’ and grandparents’ care at home, day care and residential care centres will cover all care expenses, not only medical care, without a doctor’s verification.
Selling home-use devices to the public does not change: they must be registered, and most advertising to the public needs MDA approval. See advertisement approval.
What Budget 2027 does not change
- MDA fees. Statutory fees are set by the Medical Device Regulations 2012 as amended, including by the Medical Device (Amendment) Regulations 2025. The budget does not touch them. Current figures are on our registration cost guide.
- Registration routes and timelines. No change to Act 737, the 2012 Regulations, conformity assessment or the registration timeline.
- Import duty and sales tax on medical devices. The tax measures contain no item on medical devices. The only import duty changes are for Langkawi-made goods and goods brought out of the duty-free islands.
Apakah kesan Bajet 2027 kepada syarikat peranti perubatan?
Bajet 2027, yang dibentangkan pada 9 Oktober 2026, tidak mengubah yuran, pelesenan atau pendaftaran MDA. Peruntukan Kementerian Kesihatan meningkat kepada RM47.7 bilion, dengan lebih RM770 juta untuk peralatan moden: naik taraf kemudahan hemodialisis, 400 ambulans baharu, teknologi pembedahan robotik di Hospital Pakar USM dan peralatan simulasi untuk 18 institut latihan KKM. Pembekal yang mahu menyertai tender perlu memiliki lesen establismen MDA (Surat Pekeliling MDA Bil. 1/2026), pensijilan GDPMD dan pendaftaran bagi setiap peranti. Mulai 1 Januari 2027, peniaga tempatan boleh menuntut balik cukai jualan atas jentera yang dibekalkan kepada pengilang, dan RM2.1 bilion disediakan untuk syarikat pertengahan termasuk peranti perubatan. WhatsApp 010-206 2070.
Frequently asked questions
Does Budget 2027 change MDA registration fees or licensing?
How much does Budget 2027 allocate for medical equipment?
Do I need an MDA establishment licence to supply equipment bought under Budget 2027?
Does the new sales tax refund facility help medical device manufacturers?
Is the RM2.1 billion NIMP funding open to medical device companies?
Is electronic medical record (EMR) software a medical device in Malaysia?
When do the Budget 2027 tax changes take effect?
Bidding for 2027 hospital tenders?
Send us your product list and your company’s current MDA status. We will tell you what is missing for a 2027 tender: establishment licence, GDPMD, device registrations, or installation and commissioning procedures, with a timeline that works back from the tender dates.